Conventional Stimulation in Follicular Phase vs. Luteal Phase Stimulation in Patients With Suboptimal Response. Randomized Clinical Trial. SUBLUTEAL Study

Instituto Bernabeu1 site in 1 country41 target enrollmentJanuary 17, 2020

ConditionsImproving Ovarian Stimulation; Suboptimal Responders

Interventionstime of administration of Corifollitropin Alfa

Drugstime of administration of Corifollitropin Alfa

Overview

Phase: Phase 4
Intervention: time of administration of Corifollitropin Alfa
Conditions: Improving Ovarian Stimulation; Suboptimal Responders
Sponsor: Instituto Bernabeu
Enrollment: 41
Locations: 1
Primary Endpoint: number of oocytes
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to investigate the difference in the number of oocytes obtained by performing ovarian stimulation in follicular phase vs. luteal phase in a population of patients with previous suboptimal response.

This is a controlled randomized clinical study.

We aim to include 41 patients diagnosed with suboptimal response who will undergo an ovarian stimulation in order to vitrify and accumulate oocytes.

The main variable for evaluating the efficacy in this exploratory study will be the number of oocyte cumulus complexes obtained.

Registry

clinicaltrials.gov

Start Date

January 17, 2020

End Date

April 2, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Instituto Bernabeu

Responsible Party

Principal Investigator

Jorge Sunol Sala

Instituto Bernabeu

Eligibility Criteria

Inclusion Criteria

•Meets Bologna criteria to be diagnosed as poor responder
•Less than 10 oocytes obtained in a prior controlled protocol of conventional ovarian stimulation
•Age \< 41 years
•Body Mass Index (BMI) between 18 and 32 kg/m2
•Regular menstrual cycles between 21 and 35 days.
•Indication for in vitro fertilization
•Indication to start stimulation with 150mcg of corifollitropin alpha
•Presence of both ovaries
•Ability to participate and comply with study protocol
•Signing an informed consent form

Exclusion Criteria

•Presence of follicles larger than 10 mm in the randomization visit
•Endometriosis stage III/IV
•Patients with less than 4 oocytes in previous ovarian stimulation and poor ovarian reserve parameters (as per Bologna criteria)
•Concurrent participation in another study